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There’s been a great deal of angst over contaminated drugs and drug ingredients coming from China. But this time, we have only ourselves to blame.
What may be the understatement of the year comes from the FDA after its April 30 inspection of drug manufacturing plants in Pennsylvania:

So what’s behind this massive recall?
Let’s take a closer look:
On May 4 the FDA published this inspection letter to Mr. Hakan Erdemir, Vice President of Operations at McNeil Consumer Healthcare in Fort Washington, Penn.

In it, the FDA notes, “Raw material lots had known contamination with gram negative organisms (bacteria) and were approved for use to manufacture several finished lots of Children’s and Infant’s Tylenol drug products, which remain within expiration dates on the market.”

That’s enough for me. But there’s more. The FDA inspector found the plant’s quality control office: “does not maintain adequate laboratory facilities or testing and approval (or rejection) of components and drug products; it neglects review and approval of validation protocols regarding changes in product processes and equipment to determine when revalidation is or should be warranted; it is default in investigations, tracking, trending and maintenance of consumer complaint follow-up; and it lacks trending of products, components (i.e., water), and complaints to demonstrate a broad perspective to assure plant conformance with CGMPs.”

Even Publix is apologizing. PB Post

McNeil, on the web site of its parent company Johnson & Johnson, apologizes to consumers and says it won’t restart the plant until the necessary corrective actions have been taken.